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Report from the 2014 Glaucoma 360 New Horizons Forum, by Larry Haimovitch
The third annual Glaucoma 360-New Horizons Forum, sponsored by the non-profit organization Glaucoma Research Foundation (GRF), was held in San Francisco on Friday, February 7th.
GRF is a national non-profit organization that funds glaucoma research worldwide. Since its founding 35 years ago, a total of $50 million has been raised, with 85% being directed to funding glaucoma research.
The New Horizons Forum was designed as a means to bring together worldwide leaders in medicine, science, business, venture capital and philanthropy. It is a forum to share the latest thinking and ideas for dealing with glaucoma, which because of its symptom-less nature, has often been described as a "silent thief of sight."
Robert Weinreb, MD, a world-renowned expert in glaucoma and director of the Hamilton Glaucoma Center, University of California, San Diego delivered the keynote address, which was titled "Personalizing Intraocular Pressure to Manage Glaucoma."
He noted that a physician's office reading of a patient's intraocular pressure (IOP) can be very misleading because "it does not provide information on the patient's IOP at other times during the day or later as well." He indicated that virtually every individual's IOP can vary widely during the day and will also fluctuate over a several day or weekly interval. He further said that perfusion pressure, the patient's blood pressure minus their IOP appears to be much more predictive than IOP and posed the question "if perfusion pressure is lowest at night, is this when the disease progresses the most."
Weinreb's comments on the wide variability of IOP was predicated on the findings from 24-hour IOP monitors. He specifically referred to the Triggerfish, a device which was developed by a private company Sensimed (Lausanne, Switzerland). Although Sensimed has presented at past GRF meetings it did not present this year.
This single use, contact lens like disposable sensor, which is placed on the eye generates a 24-hour IOP profile non-invasively. For the typical patient it might be done once a year or it could be used on an as needed basis. It records IOP during normal day activities and also while at undisturbed sleep. This device, which has a CE Mark but is not yet FDA approved, not only shows the levels of IOP but provides key information in the form of IOP patterns.
Another company in this space, which did present here, is privately-owned AcuMEMS (Menlo Park, California). It is developing a portfolio of wireless implantable MEMS sensors for glaucoma patients that are specifically designed for insertion in the eye during either glaucoma (that is, trabeculectomy, shunt, or stent implant) or cataract surgery. The tiny implanted sensor enables direct measurement of the IOP and sends the data wirelessly to an app on a smartphone. The smartphone in turn dispatches the IOP reading in real-time to the patient's ophthalmologist.
CEO Doug Lee announced a new initiative, an important collaborative agreement with privately-owned Digisight Technologies (Portola Valley, California). Digisight has developed a cloud based system for mobile patient monitoring. It currently offers more than ten ocular examinations with its SightBook application for mobile devices that allows a patient to test their vision frequently and share the test results with their physician in real time.
According to Lee, this agreement is important because it adds an immediate real-time data platform for AcuMEMS' IOP measurements and helps complete its product solution. This agreement will also accelerate the development time and reduce its funding requirements. AcuMEMS is currently seeking funding to complete its first in man studies and plans a pilot study to generate early clinical data for its implantable sensor.
He noted that better drug delivery devices are needed, as they will improve the dismal compliance rate with today's regimen of eye drops.
He concluded by saying that the availability of better drug delivery as well as 24-hour IOP information and management will cause a "major paradigm shift" and will be "the most disruptive and transformative developments for our glaucoma patients."
Minimally invasive glaucoma surgical (MIGS) devices were once again discussed at this year's program, as several privately-funded, venture capital backed companies presented on the clinical or commercial status of their devices. A clear indication of how important MIGS is in the venture capital community was shown when one of the presenters here, AqueSys (Aliso Viejo, California) closed a Series D round with a $44 million raise in January. This brought the total funding of the company to about $77 million.
A "back of the envelope" calculation reveals that approximately $400 million has been invested in MIGS companies to date by the venture capital community. Industry leader and MIGS market pioneer Glaukos (Laguna Hills, California), which is the only company with an FDA approval thus far, leads the pack with about $150 to $175 million in VC investment.
Presenting here, Glaukos's chief corporate development officer Bruce Nogales noted that Glaukos began its commercial efforts in late-2012 following FDA approval in mid-2012. It registered impressive revenue of about $21 million in calendar 2013, its first full year of commercialization.
Although his company has a long regulatory lead over its competitors it is clearly not resting on its laurels. Nogales cited two products in its pipeline that demonstrate that Glaukos intends to remain the industry leader. The iStent inject, which is two stents pre-loaded with an auto-injection mechanism has begun its IDE study, with a possible PMA approval in 2017. Currently, Glaukos has one IDE open for this device, with a second IDE slated to begin later this year. The second product, The iStent supra, provides a bypass via the supra-choroidal space. It has an IDE study underway with a potential PMA approval in 2018.
Nogales proudly noted that "we will be the only company able to offer a complete treatment algorithm addressing the full spectrum of glaucoma disease states and progression."
Transcend Medical (Menlo Park, California), which has raised about $61 million to date, is the next likely company to achieve FDA approval. It completed enrollment of its COMPASS domestic pivotal trial in February 2013 and is now in a FDA mandated two-year follow-up period. The trial, which enrolled 505 patients in total, utilized the company's CyPass Micro-Stent. A PMA will likely be filed in mid-2015.
The newest entrant in the MIGS space is InnFocus (Miami), whose CEO Russ Trenary presented here. InnFocus employs a fundamentally different approach to the reduction of IOP than do the other MIGS companies. Its InnFocus MicroShunt is made from a proprietary ultra-stable atraumatic and "stretchy" biocompatible biomaterial that will not provoke scar tissue in the eye. It is inserted where it can bypass the trabecular meshwork to a flap formed under the conjunctiva and Tenons, draining either into the episcleral venous system, or if too high resistance, absorbing through the conjunctiva to the tear film or both. High resistance in the episcleral venous system is believed to be a major cause of elevated IOP. It does not shunt aqueous fluid to Schlemm's Canal or the supra-choroidal space as do the other MIGS devices.
This unique approach mimics a trabeculectomy, the most widely-used glaucoma surgical procedure practiced for over 50 years. Trabeculectomy is still regarded as the gold standard in glaucoma surgery as it is by far the most effective surgical approach to lower IOP to 14 mmHg or less, which glaucoma experts believe is the upper IOP threshold required to stop the progression of vision loss. Although quite effective, trabeculectomy is fraught with serious adverse events and is highly dependent upon surgical skill.
Trenary reported that its early clinical data are very promising, with a series of 35 patients from the Dominican Republic and France followed for over two years showing an average IOP reduction of 55% from baseline to 11.3 ± 3.2 mmHg. Further, 82% of eyes had an IOP of ≤ 14 mmHg, there was an 89% reduction in glaucoma medications to 0.3 med/patient, and very impressively, 89% of patients were entirely off glaucoma medications.
InnFocus received FDA approval to begin its randomized multicenter U.S. IDE study in the spring of 2013 and began enrollment in 3Q13. The study compares the InnFocus MicroShunt to trabeculectomy in patients who have failed glaucoma medication.
InnFocus completed a Series B round of $15.4 million in mid-2013 which included the Hoya Group (Tokyo), Saints Capital Everest (San Francisco) and angel investors. It previously had raised approximately $17 million, including $10 million from Boston Scientific (Natick, Massachusetts).
Source: Medical Device Daily - February 11, 2014 edition
Last reviewed on October 29, 2017